Reuters Health Information: Infliximab use not tied to malignancy in pediatric IBD

Infliximab use not tied to malignancy in pediatric IBD

Last Updated: 2017-03-06

By David Douglas

NEW YORK (Reuters Health) - Immunosuppressive therapy with
infliximab (Remicade, Janssen) for inflammatory bowel disease
(IBD) in pediatric patients is not associated with increased
risk of malignancy or hemophagocytic lymphohistiocytosis (HLH),
according to a Janssen study.

Dr. Jeffrey S. Hyams, who worked on the study, called the
finding âreassuring.â He added in an email to Reuters Health,
âour data do suggest an association between thiopurine therapy
not only with malignancy but with another serious condition
(HLH) as well."

In a paper online February 10 in Gastroenterology, Dr. Hyams
of Connecticut Childrenâs Medical Center in Hartford and
colleagues note that associations between IBD and intestinal
malignancies are well established.

Prior reports on the risk of malignancy and HLH associated
with therapy for pediatric patients, they write, "have been
limited to largely retrospective studies with small sample
sizes."

To investigate further, the team collected and analyzed data
covering 2007 to 2014 on more than 5,700 patients no older than
17 years at enrollment. They were taking part in a prospective
study involving outcomes of Crohnâs disease, ulcerative colitis,
or unclassified IBD.

Nearly half received one or more biologics including
infliximab (94.6%), adalimumab (34.0%) and certolizumab (5.1%).
In addition to the anti-TNF alpha therapy, 232 of these patients
also received other biologics.

There were 15 cases of malignancy over the course of the
study and all five of the patients who developed HLH had been
exposed to thiopurine. Four patients were exposed to thiopurines
in the absence of biologics and all five cases of HLH occurred
during active thiopurine therapy.

Ten patients were exposed to infliximab; of these, five were
also exposed to adalimumab, six were also exposed to
methotrexate and nine were also exposed to thiopurines.

Thus, say the researchers, â13 of the 15 patients with
malignancies were exposed to thiopurines; and the majority of
these patients developed malignancy after less than 5 years of
thiopurine exposure."

Calculated standardized incidence ratios over more than
24,000 patient-years of follow-up showed no increased risk of
malignancy or HLH in patients exposed to infliximab as the only
biologic compared to those not exposed to biologics. This was
the case even when patients were stratified by thiopurine
exposure.

"Though these very serious complications remain rare,"
concluded Dr. Hyams, "clinicians may want to re-evaluate
alternatives to azathioprine use in their patients."

Janssen Scientific Affairs, LLC, funded and was involved in
all aspects of the study, including manuscript preparation. Dr.
Hyams has served as a consultant to Janssen OrthoBiotech and
three of his coauthors are or were employees of Janssen at the
time of the study. A number of other authors also reported
relationships with the company.